Status:
COMPLETED
A Multiple Dose Study of LY3209590 in Participants With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to measure the activity and insulin time action of LY3209590 at steady state in participants with type 2 diabetes mellitus. The total study duration is approximately 182 d...
Eligibility Criteria
Inclusion
- Participants with Type 2 Diabetes (T2DM).
- Participants who are insulin naive or receiving basal insulin \[NPH (neutral protamine Hagedorn) once or twice daily, once-daily insulin glargine U100 or U300, once-daily insulin degludec, or insulin detemir once or twice daily\] for fewer than 5 years prior to screening.
- Have glycated hemoglobin (HbA1c) of ≥7.0 percent (%) to ≤9.5%, HbA1c of ≥6.5% to ≤9.5% for participants on treatment with sulfonylureas and/or Sodium-Glucose Transport Protein 2 inhibitors who require washout.
- Have a body mass index between 27 and 40 kilograms per meter square.
- Male or female participants who are willing to comply with the contraception requirements consistent with local regulations.
- Be willing to allow blood sample collection, reliable and to be available for the duration of the study as required for the study protocol.
Exclusion
- Have known or suspected allergic reactions to study drugs, related compounds, excipients, and devices used in the study.
- Have a specific type of diabetes other than T2DM.
- Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
- Participants with a history of kidney complications.
Key Trial Info
Start Date :
December 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06169982
Start Date
December 7 2023
End Date
July 18 2024
Last Update
September 4 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Profil Institut für Stoffwechselforschung
Neuss, North Rhine-Westphalia, Germany, 41460